(59 days)
Not Found
No
The description details a purely mechanical wheelchair with no mention of AI/ML components or functionalities.
No
The device, a wheelchair, provides mobility assistance for physically challenged persons but does not diagnose, treat, cure, or prevent disease.
No
The device is described as providing mobility for physically challenged persons and consists of a mechanical frame with wheels, indicating it is a mobility aid rather than a tool for diagnosis. Its intended use and description do not mention any diagnostic functions, measurements, or analysis of medical conditions.
No
The device description clearly states it consists of a rigid, mechanical frame, wheels, and upholstery, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to physically challenged persons. This is a mechanical function related to physical assistance, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a mechanical device with a frame, wheels, and upholstery. This aligns with a mobility aid, not a diagnostic tool that analyzes biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases
The device described is clearly a wheelchair, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
They are intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.
Product codes (comma separated list FDA assigned to the subject device)
89IOR, IOR
Device Description
They consist of a rigid, mechanical, steel(HBG12-S)/aluminum(HBL13) frame and nylon upholstery back and seat. They have two 24" rear wheels and two 8" front casters for turning and maneuv erability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image shows a logo with the word "Hubang" written below a graphic. The graphic consists of a square with a circle inside it, and a smaller circle to the right of the larger circle. The logo appears to be distressed or aged, with a grainy texture and uneven edges.
Shanghai Hubang Medical Appliances Co., Ltd.
No.1188, Xiangyang Rd, Min Hang District, Shanghai, China, 201108 Tel: +86-21-64893645 / (34894732 Fax: +86-21-64892854 E-Mail: shhubang@vip.sina.com
510(k) Summary
Device
DEC 1 2 2008
Trade name: HUBANG HBL13/HII/G12-S manual wheelchair
Common name: Manual Wheelchai
Classification name: Mechanical wheelchair
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3850
Product Code: 89IOR
Classification: Class I
Predicate devices
Solara (K012370)/ Invacare Corpor ition
Intend use of device
They are intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.
Device description:
They consist of a rigid, mechanical, steel(HBG12-S)/aluminum(HBL13) frame and nylon upholstery back and seat. They have two 24" rear wheels and two 8" front casters for turning and maneuv erability.
Substantial equivalence:
They are substantially equivalent to the legal products in USA. They have the same technological characteristics a id intended use of the devices.
There are minor differences in performance specifications of the manual wheelchairs, these differences do not alter the intended use function and use of the device, nor do they raise ary new questions pertaining to safety or effectiveness.
Non-Clinical testing
They meet the applicable performance requirements as specified in ANSI/RESNA WC Vol. 1 Sec. 1. Sec.5, Sec.7, Sec.8, Sec.15, Sec.16 and California Bureau of Home Furnishi igs 117
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai Hubang Medical Appliances Co., Ltd. % Junnata Chang, Ph.D. 14F-2, No. 1, Lane 25, Zhuangjing Road Banqiao China (Taiwan) 220
DEC 1 2 2008
Re: K083044
Trade/Device Name: Hubang HBL13/HBG12-S Manual Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair. Regulatory Class: Class I Product Codc: IOR Dated: September 18, 2008 Received: October 20, 2008
Dear Dr. Chang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
2
Page 2 - Junnata Chang, Ph.D.
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Murk N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known):
Device Name: HUBANG HBL13/HBG12-S manual wheelchairs
Indications for Use:
To provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.
Prescription Use
Over-The-Counter Use X
(Part 21 CFR 801 Subpart D) AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083044
(Posted November 13, 2003)